NCT07387406

Brief Summary

Poor sleep is common among Asian Americans. Untreated sleep problems increase the risk of chronic diseases, cognitive decline, and mortality. Cognitive behavioral therapy for insomnia (CBTI) is considered the first-line treatment for chronic sleep problems and has demonstrated significant improvement in sleep health among older adults. However, existing CBTI is built upon Western culture, making it challenging to apply for Asian immigrants who maintain close ties to their native cultures that shape and influence their sleep habits. Addressing the lack of availability of a culturally adapted sleep intervention program is the first step to filling the gap in sleep health disparity among Asian immigrants. This study aims to pilot test the feasibility and the preliminary efficacy of a culturally adapted sleep intervention program among older Korean immigrants with poor sleep, one of the fastest-growing immigrant groups in the United States with limited access to mainstream sleep therapies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

January 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

February 24, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

January 27, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

older Korean Americanssleepbehavioral approach

Outcome Measures

Primary Outcomes (2)

  • Objective Sleep Efficiency

    Nighttime sleep efficiency (i.e., mean percent of time in bed spent asleep at nighttime) will be calculated from 7 consecutive days and nights of wrist actigraphy (Scores range from 0 to 100%, with higher values indicating better objective sleep quality)

    Immediately after the last session of the intervention

  • Subjective Sleep Quality

    Total score on the Korean version of the Insomnia Severity Index (ISI) will be used as a measure of subjective sleep (Scores range from o to 18, with lower values indicating better subjective sleep quality)

    Immediately after the last session of the intervention

Secondary Outcomes (1)

  • Acceptability of the Intervention

    Immediately after the last session of the intervention

Other Outcomes (4)

  • Feasibility of Recruitment

    Immediately after enrolled

  • Feasibility of Randomization and Retention

    Immediately after enrolled

  • Adherence to the Intervention

    Immediately after the last session of the intervention

  • +1 more other outcomes

Study Arms (2)

Sleep Intervention Program

EXPERIMENTAL

This is a culturally adapted sleep education program built upon key components of cognitive behavioral therapy for insomnia (CBT-I)

Behavioral: CBT-I based sleep intervention

Control

PLACEBO COMPARATOR

This involves with general information about sleep

Behavioral: Sleep Education

Interventions

Sleep EducationBEHAVIORAL

This group will receive information about sleep and aging, but without specific or individualized recommendations

Control

A multicomponent behavioral sleep program, consisting of sleep compression, stimulus control, sleep hygiene, relaxation, daily physical activity, and light exposure

Sleep Intervention Program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Korean immigrants (i.e., being a resident of the United States with a birthplace in Korea)
  • Able to speak, read, and write in Korean
  • Aged at least 60 years
  • Have a score of at least 15 on a Korean version of the Insomnia Severity Index
  • Able to ambulate with or without an assistive device
  • Have a score of at least 23 on a Korean version of the Montreal Cognitive Assessment (MoCA)
  • Score less than 5 on STOP-BANG (or proceed with an additional testing \[Watch Peripheral Arterial Tonometry (WatchPAT) and the Epworth Sleepiness Scale if score is equal to or greater than 5 on STOP-BANG)

You may not qualify if:

  • Those who are bedbound
  • Those who do not meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for insomnia disorder
  • Those who have an untreated apnea-hypopnea index (AHI) at least 15 (moderate obstructive sleep apnea) and Epworth Sleepiness Scale (ESS) at least 11 (indicating mild sleepiness) OR AHI is equal to or greater than 30 (irrespective of ESS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Yeonsu Song, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

February 24, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 4, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

IPD difficulty masking the identity of participants will not be shared publicly. However, all de-identified data and metadata will be made available through National Sleep Research Resource (NSRR), an NHLBI-funded resource at the time of the associated publication or the end of this project year, whichever comes first. Final research data and metadata will be shared by the end of the project period or at the time of publication, whichever is sooner, and will remain accessible indefinitely.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
by the end of the project period or at the time of publication, whichever is sooner,

Locations